Trials / Unknown
UnknownNCT03697655
Pre-emptive Daratumumab Therapy of Minimal Residual Disease Reappearance or Biochemical Relapse in Multiple Myeloma
Pre-emptive Daratumumab Therapy of Minimal Residual Disease Reappearance or Biochemical Relapse in Multiple Myeloma (PREDATOR)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 274 (estimated)
- Sponsor
- Polish Myeloma Consortium · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
PREDATOR is a study investigating a role of preemptive daratumumab therapy for preclinical relapse or progression of multiple myeloma (MM).
Detailed description
The study is composed of two phase 2 randomized multi-center substudies: * PREDATOR-BR: to investigate the role of daratumumab in the setting of biochemical relapse * PREDATOR-MRD: to investigate the role of daratumumab in minimal residual disease (MRD) reappearance
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daratumumab 20 MG/ML [Darzalex] | Daratumumab dose 16 mg/kg body weight to be administered as an IV infusion. treatment given until clinical progression or SPR but no longer than 73 weeks |
Timeline
- Start date
- 2018-12-10
- Primary completion
- 2020-09-01
- Completion
- 2024-07-01
- First posted
- 2018-10-05
- Last updated
- 2019-01-03
Locations
2 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT03697655. Inclusion in this directory is not an endorsement.